Ronan McEntee
Drogheda,Louth
Summary
Flexible and adaptable team member with 26 years' experience in Heavy Industry and Manufacturing Operations. Background in team leadership and have acquired skills in process management, machine operation, quality assurance, EHS strategies and inventory management.
Confident leader with background delivering highest work standards and safety practices in busy industrial settings. Methodical thinker with excellent organisational and communication skills. Excels at process planning, risk assessment, and team building. Takes on challenging roles harnessing interpersonal skills, collaboration and problem-solving.
Overview
29
29
years of professional experience
5
5
years of post-secondary education
Work History
Bioprocess Associate
Wuxi Biologics
Dundalk, Louth
05.2023 - Current
- Maintain Mastercontrol and complete all R&U and required OJT and ILT Training ahead of deadlines.
- Adhere to all SOP's, prioritise and promote GDP & cGMP procedures during daily operations in Cleanrooms.
- Operate Batch fed Downstream Purification using Chromatography Process including Affinity, AEX, CEX, MMC, HIC, Viral Inactivation, Diafiltration, Viral Filtration, UFDF and Bulk Filling of purified Drug Substance.
- Perform Resin Washing & Management, Column Packing, Unpacking and Repacking and process sampling as per SOP's.
- Perform all required Conditioning, Buffer additions and Filtration, ensure CPP'S & KPP's are within range and perform in process sampling and analysis to calculate Protein concentration in Drug Substance.
- Work closely with QC, FLS, Buffer Teams, MSAT, MTCE Dept, Doc Control and Manufacturing Specialists to coordinate support to ensure safe and successful completion of Batch PPQ's.
- Complete Production Batch Record reviews and practise promote GDP and a right first time mentality among team members.
- Immediately report and escalate any deviation from procedure to Shift Lead/Designee and participate in investigations. Coordinate with QA to complete and close deviations in accordance with SOP's.
- Use Delta V, Unicorn, SAP, RT Reports to perform process operations and complete PBR's for Client review.
- Assist team and support PEV, QC, MSAT with Validation, Verification and Mixing & Impurity Studies.
- Provide OJT training to team members and MFG 6.1, MFG 6.2 & MFG 7 colleagues.
- MFG 7 Safety Representative, promote and encourage safe working practices among colleagues to ensure personnel and operational safety at all times. Assist & support EHS Team implementing new and updated safety initiatives to MFG Dept.
Shift Charge Hand / Deputy Head of Shift
Premier Periclase Ltd
Drogheda, Louth
12.2007 - 10.2022
- Managed and maintained operation of plant to achieve production targets and produce high grade material for shipping and export.
- Supervised and assisted team of 8 operatives to consistently deliver maximum plant output while ensuring full implementation of all SOP's and EHS procedures.
- Proactively promoted cGMP (Good Manufacturing Practice) and CIP (Continuous Improvement Program) among team members. Implemented Pre & Post Work briefings to gather immediate feedback from team to improve work practices and safety standards.
- Continuously review and update SOP's to incorporate new technological designs, updated QMS ISO 14001 procedures, EHS OHSAS 18001 regulatory requirements and IT systems developments.
- Strict enforcement of Safety SOP's and Risk Assessment analysis of tasks such as Confined Space Entry, Hot Works Area Permits, Hazardous Chemical Awareness and Chemicals Handling and Safe Storage, Cleanroom Environment Procedures.
- Performed laboratory testing and analysis hourly throughout manufacturing process to assess product quality and maintain grade specification.
- Monitored KPI's of plant and machinery and performed daily maintenance to eliminate stoppages impacting on targets and schedules.
- Coordinated daily production planning meetings with Mechanical & Electrical maintenance department managers, managed shift manning levels, overtime requirements and call-in roster.
- Proactively implemented Lean Six Sigma with focus on maximum productivity, accurate record keeping, eliminating waste, energy consumption awareness and cost saving initiatives.
- Supervised team to ensure cGMP was maintained in compliance with ISO 9001 2015 standards and coordinated with internal and external audits and EHS Management Team.
- Promote meticulous and accurate record keeping and immediate reporting of internal defects. Lead investigations and determine root cause analysis followed by implementation of corrective actions.
- Delivered ongoing training to team members, promoted and encouraged team building exercises to improve interpersonal awareness and create forums to share ideas.
Warehouse/Maintenance Operative
Coca Cola
Drogheda, Louth
06.2005 - 10.2007
- Generated and accurately recorded all Purchase Orders from outside vendors.
- Selected, packed and dispatched up to 30 orders daily, consistently meeting warehouse performance targets.
- Independently worked through high-volume orders using initiative and self-motivation, consistently hitting deadline targets.
- Coordinated stock deliveries for multiple departments to deliver production targets while proactively securing best value through vendor price comparison to maximise budget.
- Monitored and undertook regular Stress Tests of equipment and machinery to ensure efficient and effective supply of replacement parts to maintain maximum operational output.
- Strict compliance with cGMP and SOP's in Laboratory and Clean Rooms, Cold Storage Facilities and Effluent Treatment Plant to assess up to date certification and replacement and tagging of all performing and nonperforming equipment and machinery.
- Coordinated daily meetings with Production and Technical Maintenance teams to ensure order targets and schedules were met. Perform post task inventory checks on SAP and maintain effective running of plant.
- Reported daily to Maintenance Manager on defects and breakages to enable prompt and effective resolutions.
Injection moulding machine operator
Thorsman Ireland Ltd
Drogheda, Louth
03.1996 - 04.2005
- Injection Moulding Operator
- Operated 6 high temperature injection moulding machines to achieve production targets.
- Prepared machines with pre and post operational inspections.
- Modified machine set up and templates to achieve product specification.
- Implemented all SOP's during process in coordination with QA Team to maintain grade specification.
- Recorded shift production progress and updated project targets achieved on SDS Management Systems.
- Liaised with Maintenance Dept and QC Dept to maintain continuous operational output and achieve in process sampling targets.
Education
High School Diploma -
St Mary's Diocesan School
Drogheda, Louth 09.1990 - 06.1995
Skills
- Machine Operation
- Tech Support & IT Systems: Delta V, Unicorn, SAP, Honeywell, SDS, Microsoft Word/Excel
- UV Spectrometer & PH & Conductivity Meter trainer
- FMEA Technique Application
- 7 Step Problem Solving
- Lean Six Sigma implementation
- Employer GMP training module
- First Aid Training & Certification
- Warehouse & Inventory Management Course
- Previous Vehicle Operator certification: MEWPS, Teleporter, Skid Shovel, Skid Steer, Fork Truck
Timeline
Bioprocess Associate
Wuxi Biologics
05.2023 - Current
Shift Charge Hand / Deputy Head of Shift
Premier Periclase Ltd
12.2007 - 10.2022
Warehouse/Maintenance Operative
Coca Cola
06.2005 - 10.2007
Injection moulding machine operator
Thorsman Ireland Ltd
03.1996 - 04.2005
High School Diploma -
St Mary's Diocesan School
09.1990 - 06.1995
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